LZA · Class I · 21 CFR 880.6250

FDA Product Code LZA: Polymer Patient Examination Glove

Examination gloves are among the most used medical devices in healthcare settings. FDA product code LZA covers polymer patient examination gloves — including nitrile, vinyl, and other synthetic materials.

These gloves provide a protective barrier between healthcare workers and patients during examination and non-surgical procedures. Nitrile gloves are the preferred choice for latex-sensitive patients and clinicians.

LZA devices are Class I medical devices, regulated under 21 CFR 880.6250 and reviewed by the FDA General Hospital panel.

Leading manufacturers include O&M Halyard, Inc., Medline Industries, Inc. and Shen Wei (Usa), Inc..

1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
361–384 of 1170
Cleared Jul 28, 2021
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
K211455
Shen Wei (Usa), Inc.
General Hospital · 79d
Cleared Jul 23, 2021
Nitrile Patient Examination Gloves
K211012
Huayuan Medical Technology(Shangqiu) Co., Ltd.
General Hospital · 109d
Cleared Jul 22, 2021
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
K211220
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 90d
Cleared Jul 21, 2021
Nitrile Patient Examination Glove
K210686
Yunnan Huazhiyuan Medical Technology Co., Ltd.
General Hospital · 135d
Cleared Jul 20, 2021
Disposable Nitrile Medical Examination Glove
K210684
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 134d
Cleared Jul 15, 2021
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K211547
Edma Group, LLC
General Hospital · 57d
Cleared Jul 12, 2021
Nitrile Patient Examination Glove
K210723
Jiangxi Zhonghong Pulin Medical Products Co., Ltd.
General Hospital · 124d
Cleared Jul 12, 2021
Nitrile Examination Gloves
K210776
5r Med Instruments (Chengdu) Co., Ltd.
General Hospital · 119d
Cleared Jul 10, 2021
Medical Nitrile Examination Gloves (Power free, Blue)
K210578
Jiangxi Hongda Medical Equipment Group , Ltd.
General Hospital · 134d
Cleared Jun 28, 2021
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K210587
Onetexx Sdn Bhd
General Hospital · 122d
Cleared Jun 28, 2021
White Nitrile Powder Free Patient Examination Glove, Non Sterile
K210775
Onetexx Sdn Bhd
General Hospital · 105d
Cleared Jun 25, 2021
Nitrile Glove
K211252
Jiangsu Dihong Industry and Trade Co., Ltd.
General Hospital · 60d
Cleared Jun 24, 2021
Powder Free Black Nitrile Examination Glove
K201428
Vietglove Corporation
General Hospital · 391d
Cleared Jun 21, 2021
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
K202085
Shen Wei (Usa), Inc.
General Hospital · 329d
Cleared Jun 21, 2021
Powder Free Blue Nitrile Examination Glove
K210375
Duramitt Sdn Bhd
General Hospital · 133d
Cleared Jun 16, 2021
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
K211310
Megine Industries Sdn Bhd
General Hospital · 47d
Cleared Jun 13, 2021
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K210401
Ansell Healthcare Products, LLC
General Hospital · 123d
Cleared Jun 04, 2021
Nitrile Patient Examination Gloves
K211028
Huayuan Medical Technology(Shangqiu) Co., Ltd.
General Hospital · 59d
Cleared May 13, 2021
Powder Free Nitrile Examination Glove
K210369
Pastel Glove Sdn Bhd
General Hospital · 94d
Cleared May 07, 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
K203036
Central Medicare Sdn Bhd
General Hospital · 214d
Cleared May 07, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K210366
Onetexx Sdn Bhd
General Hospital · 88d
Cleared May 07, 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755
Meditech Gloves Sdn Bhd
General Hospital · 53d
Cleared Apr 29, 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
K210944
Harbour Health, LLC
General Hospital · 30d
Cleared Apr 28, 2021
Disposable Nitrile Examination Gloves
K203436
Shandong Zhushi Pharmaceutical Group Co., Ltd.
General Hospital · 156d